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Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceuticals, Los Angeles, CA. Amended 483 Issued 03/23/2017
Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceuticals, Los Angeles, CA. Amended 483 Issued 03/23/2017Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page
Record Date 03/23/2017
FEI Number 3013341563
Firm Name Fusion IV Pharmaceuticals Inc. dba Axia PFDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters
This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramEarly Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure IssuesFresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mgWound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products
Integra is removing certain Wound and Burn Dressing products that may have breached sterile barriers.
